Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last Reply	Views
FDA: ANDA Submissions—Amendments to ANDAs Under GDFUA	Helmut	2018-08-09 10:52	0		141
EMA: Q&A Update EMA: Q&A Update The early bird gets the worm The early bird gets the worm but Lambda Therapeutic Ltd.? Lambda Therapeutic Ltd.? EMA: Q&A Update; Expected studies for Quetiapine PR Tablets	Helmut	2013-11-15 13:53	6	2018-08-06 14:42	6,785
EMA: 2 product-specific guidances adopted EMA: New product-specific draft guidances published EMA: New product-specific draft guidance published EMA: 5 product-specific guidances adopted	Helmut	2018-06-26 14:40	3	2018-08-03 16:52	976
New FDA BMV guideline What a monster! What a monster! Two Versions: May 21 & May 24 Repeats as part of investigations, ja oder nein? Repeats as part of investigations, ja oder nein? Two Versions: May 21 & May 24 Requirements ⇒ recommendations Requirements ⇒ recommendations	Ohlbe	2018-05-21 16:28	8	2018-08-02 22:59	1,290
ICH M9 Draft	Helmut	2018-07-16 14:49	0		311
Updated TPD BE guidances Updated TPD BE guidances Canada-Comparative bioavaiability standards	BRB	2018-06-18 22:53	2	2018-06-27 12:36	588
New EMA guideline: Handling and shipping of IMPs	Helmut	2018-05-24 15:45	0		471
Shenanigans	ElMaestro	2018-04-15 14:50	0		465
Revision of the BE-GL? ...and much more Postponed: New target date Q4 2018 Postboned: New target date Q4 2018 Postponed: New target date Q4 2018	Helmut	2017-04-29 15:26	4	2018-02-15 13:32	2,307
Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud One more One more Fraud Kill the messenger Kill the messenger Kill the messenger Kill the messenger	Helmut	2016-04-24 13:14	18	2018-02-15 01:28	10,174
Brexit Brexit	Helmut	2017-12-12 12:50	1	2018-01-10 11:56	1,113
Levothyroxine: A black swan? Levothyroxine: A black swan? Levothyroxine: A black swan? Were physicians/patients aware of the change in the formulation? Were physicians/patients aware of the change in the formulation? Were physicians/patients aware of the change in the formulation? Levothyroxine: A black swan? Levothyroxine: A black swan? Levothyroxine: A black swan?	Helmut	2017-11-26 12:51	8	2017-11-28 08:53	9,291
Whistleblowers, stand up! Whistleblowers, stand up! Whistleblowers, stand up! This isn't about whistleblowers This isn't about whistleblowers This isn't about whistleblowers	Helmut	2017-05-23 14:12	5	2017-05-25 12:37	2,271
Interesting Article WHO: healthy volunteers should be healthy...	Helmut	2017-03-19 15:45	1	2017-03-23 10:47	1,513
EMA BE-GL: Clarifications / Corrections? Good news!? Good news!? Update Q&A published 14 March 2011 Q&A published 14 March 2011 Phoenix/WinNonlin 6.1.0.173 ANOVA party prevails THX! Outlier Outliers - yes, but how? Questions and Ambiguities Residuals and Outliers in Replicate Design Crossover Studies Info requested Confused as well... Q&A published 14 March 2011 SAS code: Warning Copy & paste Subtleties, flaws, questions Subtleties, flaws, questions Not estimable in the model Not estimable in the model Not estimable in the model Not estimable in the model Not estimable in the model	Helmut	2010-06-22 18:53	24	2017-03-18 21:59	20,664
Latest EMA drafts on indidividual compounds	nobody	2017-01-03 12:31	0		1,213

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